FDA.reportPublic FDA data

Leader Allergy Relief

Product NDC
70000-0213
11-digit product format
700000213
Labeler code
70000
Product ID
70000-0213_ef5ff212-8517-4598-9876-2ba32b9d360b
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA076301
Marketing category
ANDA
Marketing start
2016-12-09
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0213-1Leader Allergy Relief1 in 1 BLISTER PACKTABLET16
70000-0213-1Leader Allergy Relief10 in 1 CARTONTABLET106
70000-0213-2Leader Allergy Relief30 in 1 CARTONTABLET306
70000-0213-2Leader Allergy Relief1 in 1 BLISTER PACKTABLET16
70000-0213-3Leader Allergy Relief70 in 1 BOTTLETABLET706
70000-0213-3Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-4Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-4Leader Allergy Relief90 in 1 BOTTLETABLET906
70000-0213-5Leader Allergy Relief1 in 1 BLISTER PACKTABLET16
70000-0213-5Leader Allergy Relief40 in 1 CARTONTABLET406
70000-0213-6Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-6Leader Allergy Relief300 in 1 BOTTLETABLET3006
70000-0213-7Leader Allergy Relief1 in 1 CARTONTABLET16
70000-0213-7Leader Allergy Relief100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0213-1EA - Each70000-0213280b30f0-4942-4116-bf61-e1e1bc2163ca12017-11-06
70000-0213-2EA - Each70000-02134174a45f-ef34-487d-b9bf-1e702d79252112017-11-06
70000-0213-3EA - Each70000-0213463d9a05-fd01-42db-8da7-eaeaab22f77b12017-11-06
70000-0213-4EA - Each70000-0213f2f06829-87f9-4f02-93c3-50448d007a7e12017-11-06
70000-0213-5EA - Each70000-0213504c440b-543f-4806-89ab-d5c035ff038212018-08-13
70000-0213-6EA - Each70000-021335c7fb4b-4abb-414b-8f70-32c818608a3912020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0213LEADER ALLERGY RELIEF (LORATADINE) TABLET [CARDINAL HEALTH 110, LLC. DBA LEADER]6Current NDC, Legacy NDC, 14 package rows20250403_6f5134c6-ece6-4e35-a0c3-13e0dfa173fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN6f5134c6-ece6-4e35-a0c3-13e0dfa173fa6
311372loratadine 10 MG Oral TabletSCD6f5134c6-ece6-4e35-a0c3-13e0dfa173fa6
311372loratadine 10 MG 24 HR Oral TabletSY6f5134c6-ece6-4e35-a0c3-13e0dfa173fa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0213-17000002130110 BLISTER PACK in 1 CARTON (70000-0213-1) / 1 TABLET in 1 BLISTER PACK10 blister pack2016-12-090000-00-00NoNoCurrent
70000-0213-27000002130230 BLISTER PACK in 1 CARTON (70000-0213-2) > 1 TABLET in 1 BLISTER PACK30 blister pack2016-12-090000-00-00NoNoCurrent
70000-0213-3700000213031 BOTTLE in 1 CARTON (70000-0213-3) / 70 TABLET in 1 BOTTLE1 bottle2016-12-090000-00-00NoNoCurrent
70000-0213-4700000213041 BOTTLE in 1 CARTON (70000-0213-4) / 90 TABLET in 1 BOTTLE1 bottle2016-12-090000-00-00NoNoCurrent
70000-0213-57000002130540 BLISTER PACK in 1 CARTON (70000-0213-5) > 1 TABLET in 1 BLISTER PACK40 blister pack2017-12-130000-00-00NoNoCurrent
70000-0213-6700000213061 BOTTLE in 1 CARTON (70000-0213-6) / 300 TABLET in 1 BOTTLE1 bottle2020-01-140000-00-00NoNoCurrent
70000-0213-7700000213071 BOTTLE in 1 CARTON (70000-0213-7) / 100 TABLET in 1 BOTTLE1 bottle2025-04-01NoNoHistorical